Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

[Posted 09/11/2012]

AUDIENCE: Consumer, Health Professional

ISSUE:  Today, Qualitest, a subsidiary of Endo Health Solutions,issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

BACKGROUND: Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lot, C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.

RECOMMENDATION: Consumers who have lot C1440512A should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot number should consult their pharmacy or health care professional. Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at 1-800-967-5952 for instructions on product return.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/11/2012 - Press Release - FDA]